Pharmacological Activation of HMN for OSA



Status:Recruiting
Conditions:Insomnia Sleep Studies, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 70
Updated:11/21/2018
Start Date:October 30, 2018
End Date:December 31, 2019

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Trial Summary
Trial Overview
Inclusion Criteria

Pharmacological Activation of Hypoglossal Motor Nucleus for Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) is common and has major health implications but treatment
options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle
activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared
to normal subjects. In this protocol the investigators will test the effect of LTM1201L,
LTM1201LN, LTM1201LB, LTM1201LD administered before sleep on OSA phenotype traits and OSA
severity during sleep.


Inclusion Criteria:

- AHI > 10 events/h during NREM supine sleep

Exclusion Criteria:

- Any medical condition other than well controlled hypertension and mild diabetes.

- Any medication known to influence breathing, sleep/arousal, or muscle physiology.

- Claustrophobia.

- Inability to sleep supine.

- Allergy to any of the medications tested in the protocol.

- History of kidney stones, hypercalcemia, primary hyperparathyroidism, sarcoidosis,
hypervitaminosis D.

- Individuals with underlying cardiac disease, such as arrhythmias.

- Individuals taking psychiatric medications, such as an MAO-I, SSRI or SNRI, or any of
the studied medications for medical care.

- For women: Pregnancy.

- Pulmonary hypertension

- Severe OSA with a mean SaO2 lower than 88%
We found this trial at
1
site
Sleep Disorders Research Program Brigham and Women's Hospital
Boston, Massachusetts 02115
Principal Investigator: Luigi Taranto Montemurro, MD
Phone: 617-732-8976
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mi
from
Boston, MA
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